Effectiveness of expectant management versus methotrexate in tubal ectopic pregnancy: a double-blind randomized trial

To compare the effectiveness of expectant management versus methotrexate in selected cases of tubal ectopic pregnancy. A double-blind randomized trial included 23 selected patients with a confirmed diagnosis of tubal pregnancy who met the inclusion criteria (hemodynamic stability, initial serum beta-hCG concentration < 2,000 mIU/mL, declining titers of beta-hCG 48 h prior to treatment, visible tubal pregnancy on transvaginal ultrasound, a tubal mass < 5.0 cm and fertility desire). The patients were divided into two groups: 10 patients in the methotrexate group (MTX 50 mg/m(2) administered as a single intramuscular dose) and 13 patients in the placebo group (saline solution administered in a single intramuscular dose). Quantitative variables were expressed as means +/- A standard deviations and compared by Student's t test or Mann-Whitney test. Dichotomous variables (success/treatment failure) were presented as proportions and compared by the Fisher exact test. Successful treatment with negative titers of beta-hCG occurred in 9 cases (90.0 %) of the methotrexate group and in 12 (92.3 %) of the placebo group (p > 0.999). The beta-hCG values became undetectable at 22 +/- A 15.4 days in the methotrexate group and 20.6 +/- A 8.4 days in the placebo group (p = 0.80). This study showed no statistically significant difference between the treatment with methotrexate and placebo, with similar success rates and similar time interval for beta-hCG to become undetectable.